PROUD Study - Preventing Opioid Use Disorders

June 15, 2023 updated by: Kelly Wiltse Nicely, Emory University
The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. The study team identified alternative pharmacologic methods to block pain pathways to reduce or even eliminate the need for opioids in the intra- and postoperative periods, with the goal of decreasing or eliminating exposure to opioids. A secondary objective is to assess two core competencies for interprofessional collaborative practice (Interprofessional Communication and Teams; and Teamwork) within the interprofessional care team implementing the opioid free protocol.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Orthopaedic and Spine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria Intervention group:

  • Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021

Inclusion Criteria Control:

  • Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February through May, 2020

Inclusion Criteria Professional Staff:

  • All staff that participate in the implementation of the opioid free surgical protocol.

Exclusion Criteria:

  • Participants that do not speak English will not be eligible for participation in the study.
  • Individuals less than 18 years of age will not be included for participation in the study.
  • Individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective cases undergoing non-opioid drug regimen
Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Behavioral: Guided mindfulness exercises
Guided Meditation twice daily
Other: Self-administered aromatherapy
Self-administered aromatherapy every 6 hours and at bedtime
Drug: Baby aspirin
Baby aspirin 81mg: Twice daily for 6 weeks after surgery
Drug: Tylenol/Acetaminophen
Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
Drug: Pregabalin

Pregabalin 25mg:

Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery

Drug: Prednisone
Prednisone 5mg: Daily for three weeks after surgery
Drug: Meloxicam

Meloxicam 7.5mg:

Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery

Drug: Prilosec

Prilosec 20mg:

Daily for two weeks before surgery; Daily for for two weeks after surgery

Drug: Tramadol
Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
Drug: Voltaren
Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
Drug: Zofran
Zofran 4 mg pre-operative
Drug: Pepcid
Pepcid 20 mg pre-operative
Drug: Reglan
Reglan 10 mg pre-operative
Drug: Versed
Versed 2 mg pre-operative
Drug: Lidocaine
Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
Drug: Propofol
Propofol 10-125 mcg/kg/min intraoperative
Drug: Ancef
Ancef 2-3 gm weight-based dosing intraoperative
Drug: Tranexamic Acid (TXA)
Tranexamic Acid (TXA) 2 gm intraoperative
Drug: Decadron
Decadron 10 mg intraoperative
Drug: Bupivacaine hydrochloride
Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
Drug: Toradol
Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative
No Intervention: Retrospective control underwent opioid drug regimen
Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively
No Intervention: Professional Staff
Staff that participate in the implementation of the opioid free surgical protocol will be completing team assessment surveys seeking their opinion about interprofessional teamwork and communication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
Time Frame: Up to 5 weeks
Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication.
Up to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
Time Frame: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration.
Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Wiltse Nicely, PhD, CRNA, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

December 27, 2021

Study Completion (Actual)

December 27, 2021

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in peer reviewed publication(s) will be shared after de-identification.

IPD Sharing Time Frame

Data will be available for sharing beginning 6 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Data will be available for sharing with investigators whose proposed use of the data have been approved by an independent review committee identified for that purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in Emory University's data warehouse but without investigator support other than deposited metadata. Information regarding the Emory Dataverse can be found at: http://sco.library.emory.edu/dataverse/index.html

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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